Monthly Archives: December 2012

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BALTIMORE (WJZ)– The former lab tech accused of exposing hundreds of
people to Hepatitis C is now believed to have more victims here in
Baltimore. Monique Griego has more on where these patients were infected.

Federal prosecutors believe the suspect infected dozens of people.
All of these new patients were believed to have come in contact with the
suspect while being treated at Johns Hopkins Hospital.

A doctor with hepatitis B who preformed joint replacement surgeries
unknowingly passed the virus on to at least two of his patients,
according to a new report.

The report, issued by researchers at the University of Virginia Health System, said the surgeon first became aware that he had hepatitis B
after he stuck himself with a needle, and underwent routine testing for
blood-borne diseases. The surgeon had emigrated from a country that had
a high prevalence of hepatitis B, and likely had had chronic hepatitis B
for some time without showing symptoms, such as fever and nausea.

The report was published in the journal Clinical Infectious Diseases in October 2012, but the incident occurred in 2009.

A large number of patients with chronic hepatitis C are vitamin A
deficient, and this deficiency is associated with nonresponse to
treatment, according to recent results.

In a multicenter study, researchers compared the serum vitamin A and vitamin D levels in 199 treatment-naive patients with chronic hepatitis C, before receiving interferon (IFN)-based antiviral therapy, with those of 119 healthy controls.

Ted Adamson of Riverside, Calif., nearly lost his liver and life to the disease

FRIDAY, Dec. 21 (HealthDay News) — Ted Adamson’s liver had been so
ravaged by the hepatitis C virus that he was nearly at the point of
needing a liver transplant. Yet he had no symptoms. None. He didn’t even
feel tired.

Fortunately for Adamson, a move from one state to another had
prompted a health insurance change, and his new doctor suggested a
battery of tests, including a hepatitis C test. Adamson wasn’t
particularly concerned about hepatitis C, but because he’d had a blood
transfusion after an accident in the mid-1970s, and he’d been a drug
user in his late teens and 20s, he agreed to the test.

Press release

13-Dec-12
Stockholm, Sweden—Medivir AB (OMX: MVIR), announced today the initiation
of cohort 2 in the interferon-free phase II trial combining simeprevir
with sofosbuvir (GS7977) based on a safety and efficacy planned interim
analysis of cohort 1 including prior null responder HCV genotype 1
infected patients without advanced hepatic fibrosis. Data from the
cohort 1 study will be presented at a scientific conference during
H1-2013.

Study designSimeprevir, a NS3/4A protease inhibitor
is being studied with sofosbuvir, a nucleotide NS5B polymerase
inhibitor, in a phase IIa, randomized, open-label study to investigate
the efficacy and safety of 12 or 24 weeks of simeprevir (150 mg QD) and
sofosbuvir (400 mg QD) with or without ribavirin (RBV) in HCV genotype 1
(GT1) patients.

Cohort 1 included a total of 80 HCV GT1 prior null responders to PegIFN/RBV therapy with METAVIR score F0-F2.

About Simeprevir (TMC435)Simeprevir
is a once-daily potent investigational hepatitis C protease inhibitor
in late phase III clinical development being jointly developed by
Medivir AB and Janssen R&D Ireland to treat chronic hepatitis C
virus infections. Simeprevir is being investigated in combination with
PegIFN/RBV in phase III trials and is also being evaluated with
direct-acting antiviral (DAA) agents in three other phase II interferon
free combinations both with and without ribavirin (RBV). Global phase
III studies of simeprevir include QUEST-1 and QUEST-2 in treatment naïve
patients, PROMISE in patients who have relapsed after prior IFN-based
treatment and ATTAIN in treatment experienced patients. In parallel to
these trials, phase III studies for simeprevir are ongoing in both
treatment naïve and treatment experienced HIV-HCV co-infected patients,
HCV genotype 4 infected patients and in Japanese HCV genotype 1
patients.

About Hepatitis CHepatitis
C is a blood-borne infectious disease of the liver and is a leading
cause of chronic liver disease and liver transplants. The World Health
Organization estimates that nearly 170 million people worldwide,
approximately 3% of the world’s population, are infected with hepatitis C
virus (HCV). The CDC (Centers for Disease Control and Prevention) has
reported that more than three million people in the United States are
chronically infected with HCV.

About MedivirMedivir is an
emerging research-based pharmaceutical company focused on infectious
diseases. Medivir has world class expertise in polymerase and protease
drug targets and drug development which has resulted in a strong
infectious disease R&D portfolio. The Company’s key pipeline asset
is simeprevir (TMC435), a novel protease inhibitor in phase III clinical
development for hepatitis C that is being developed in collaboration
with Janssen R&D Ireland. In June 2011, Medivir acquired the
specialty pharmaceutical company BioPhausia and today Medivir has a
broad product portfolio with prescription pharmaceuticals in the
Nordics.

For more information about Medivir, please visit the Company’s website: www.medivir.com

Medivir
is a collaborative and agile pharmaceutical company with an R&D
focus on infectious diseases and a leading position in hepatitis C. We
are passionate and uncompromising in our mission to develop and
commercialize innovative pharmaceuticals that improve people’s lives

Results from the QUEST-1
and QUEST-2 trials found that 80% and 81% of treatment-naive patients
with chronic genotype 1 hepatitis C infection who were treated with
simeprevir achieved sustained virologic response 12 weeks after the
planned end of treatment (SVR12). Results from the PROMISE trial found
that 79% of prior relapsed patients treated with simeprevir achieved
SVR12. All three studies utilized response-guided treatment (RGT)
criteria and 85%, 91% and 93 % of the patients, respectively, were
eligible to stop all treatments after 24 weeks.

The overall
safety, tolerability and efficacy results from these studies were
consistent with those previously obtained in phase II studies.

Final
analysis of the phase III trials is ongoing and the full data set from
these studies will be submitted for presentation at future scientific
conferences.

“We are extremely happy about the data from these
phase III studies, which robustly demonstrate high cure rates in both
treatment-experienced, so called relapsers, and treatment-naïve patient
groups, both including patients with severe liver disease. Together with
the very good safety profile and the fact that a large proportion of
the patients were eligible to end all treatments in a shorter time frame
as compared to current standard of care, should provide new hope for
large patient groups with this disease”, said Charlotte Edenius, EVP of
Research and Development, Medivir AB. “We look forward to seeking
regulatory approvals to bring simeprevir forward to help treat people
living with chronic hepatitis C.”

QUEST-1 (C208), QUEST-2 (C216) and PROMISE (C3007)

In
the global QUEST-1 and QUEST-2 trials, 394 and 391 respectively,
treatment-naïve patients with genotype 1 hepatitis C were randomized to
receive either 150 mg of once-daily simeprevir for 12 weeks plus
pegylated interferon and ribavirin for 24 or 48 weeks based upon
response guided treatment criteria (simeprevir group) or pegylated
interferon and ribavirin alone for 48 weeks (control group).

In
the PROMISE study, 393 patients, who had previous relapse after
completing HCV treatment with pegylated interferon and ribavirin, were
randomized to receive either 150 mg of once-daily simeprevir for 12
weeks plus pegylated interferon and ribavirin for 24 or 48 weeks based
on response guided treatment criteria (simeprevir group) or pegylated
interferon and ribavirin alone for 48 weeks (control group).

Summary – Safety and TolerabilitySimeprevir was
generally safe and well tolerated and overall incidence of adverse
events (AEs), including rash and anemia was similar to the placebo
control and consistent with prior simeprevir phase II studies.

In
all three phase III studies, AEs leading to permanent discontinuation
were lower in the simeprevir treated subjects compared to the placebo
control (pegylated interferon and ribavirin).

Mild and reversible
increases in bilirubin (total, direct and indirect) were observed in
simeprevir dose groups. There were no meaningful differences between
treatment groups for any of the other laboratory parameters. There were
no clinically significant findings on vital signs. Mean alanine
aminotransferase (ALT) levels decreased in all simeprevir treatment
groups.

The conference call will also be streamed live via a link on the website: www.medivir.com

About Simeprevir (TMC435)Simeprevir,
a potent investigational NS3/4A protease inhibitor jointly developed by
Janssen and Medivir, is currently in phase III studies as a one pill
once-daily treatment taken in combination with pegylated interferon and
ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C
infection.

Global phase III studies of simeprevir include
QUEST-1 and QUEST-2 in treatment-naïve patients, PROMISE in patients who
have relapsed after prior interferon-based treatment, ATTAIN in prior
null-responder patients and studies in Japanese HCV genotype 1 patients.
In parallel to these trials, phase III studies for simeprevir are
ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected
patients and in HCV genotype 4 patients.

Simeprevir is also being studied in phase II interferon-free trials both with and without ribavirin:

About Hepatitis CHepatitis
C is a blood-borne infectious disease of the liver and is a leading
cause of chronic liver disease and liver transplants. The World Health
Organization estimates that nearly 170 million people worldwide,
approximately 3% of the world’s population, are infected with hepatitis C
virus (HCV). The CDC (Centers for Disease Control and Prevention) has
reported that more than three million people in the United States are
chronically infected with HCV.

About MedivirMedivir is an emerging research-based pharmaceutical company focused on infectious diseases.

Medivir
has world class expertise in polymerase and protease drug targets and
drug development which has resulted in a strong infectious disease
R&D portfolio. The Company’s key pipeline asset is simeprevir
(TMC435), a novel protease inhibitor in phase III clinical development
for hepatitis C that is being developed in collaboration with Janssen
R&D Ireland.

In June 2011, Medivir acquired the specialty
pharmaceutical company BioPhausia and today Medivir has a broad product
portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir, please visit the Company’s website: www.medivir.com

Representatives
Bill Cassidy (R-LA), Michael Honda (D-CA), Hank Johnson (D-GA), and
Barbara Lee (D-CA) are taking a leadership role in responding to the
U.S. Preventive Services Task Force’s disappointing draft “C”
recommendation for testing Baby Boomers for hepatitis C. They are
circulating a sign-on letter among their colleagues that urges the
USPSTF to change the grade to an “A” or a “B” when it finalizes its
recommendations (see letter below).

This
letter is an extremely important tool in convincing the USPSTF to
improve its grade. We need as many House Representatives as possible to
sign this letter. Please take a few minutes to call your Representative
and ask him/her to sign!

How you can help:

Please
call your House Representative’s Washington, DC office as soon as
possible, and before January 4, 2013 (the deadline for signing the
letter).

Ask
to speak with the staffperson who handles health care issues. Whether
you leave a voicemail or speak with the staffperson live, tell him/her:

“My
name is ____________ and I live in (city). I am calling to urge
Representative _____________ to sign the bi-partisan letter by
Representatives Cassidy, Honda, Johnson, and Lee that urges the U.S.
Preventive Services Task Force to improve its recommended “C” grade for
hepatitis C testing. We need a stronger USPSTF recommendation in order
to identify the millions of Americans who have hepatitis C and don’t
know it. If you have questions about the letter, or wish to sign, please
contact A.J. Bhadelia in Representative Honda’s office, Scott Goldstein
in Representative Johnson’s office, or Robb Walton in Representative
Cassidy’s office.”

You can reach your House Representative through the Capitol Switchboard, (202) 224-3121.

Bi-Partisan Call to USPSTF to Change its Hepatitis C Recommendation

Join the Bi-Partisan Call to USPSTF to Change its Hepatitis C RecommendationDeadline: 1/4/13

Dear Colleague,
Please
join us in writing a bi-partisan letter to the U.S. Preventative
Services Taskforce (USPSTF) encouraging them to change their recommended
“C” grade for hepatitis C (HCV) screening among baby boomers. As you
may know, earlier this year, the Centers for Disease Control and
Prevention (CDC) released new HCV screening guidelines recommending that
providers offer the screening to anyone born in this birth cohort. The
recommended grade of a “C” from the USPSTF falls disconcertingly short
of meaningfully implementing the CDC’s recommendation. The USPSTF states
that there is only a “small benefit” for testing those who do not have
symptoms, despite the fact that HCV can remain asymptomatic for years.

CDC
took an important first step in changing the testing paradigm around
HCV for the better and improving health outcomes for millions of
Americans. CDC’s guidelines are based on a systematic review of a
comprehensive body of evidence, evidence such as age-based methods that
we encourage the USPSTF to use to align itself more closely with the
CDC’s recommendations. Of additional concern is the fact that the USPSTF
does not have a consistent public definition for the “C” grade. While a
“C” recommendation appears to put the decision to screen in the hands
of the individual physician, the USPSTF notes that the “C” statement is
“undergoing revision.” This could create a significant level of
confusion as physicians determine how to incorporate the recommendation
into practice.

It is critical we prioritize the
identification of HCV-infected baby boomers in order to meet the goals
of the Department of Health and Human Services’ Viral Hepatitis Action
Plan. Of the estimated 3.2 million persons living with HCV, 45 to 85
percent remain unaware of their infection and are not linked to the
life-saving care and treatment that are needed to avoid progression to
liver disease, cirrhosis or liver cancer. Persons born between 1945
and1965 have the greatest risk for HCV related morbidity and mortality,
and therefore, would see the greatest benefit from HCV screening.

Dear Dr. Moyer,
We
write to you on behalf of the more than 5.3 million people living with
viral hepatitis in the United States, a large portion of whom remain
unaware of their infection, to encourage you to change your recommended
“C” grade for hepatitis C (HCV) screening among baby boomers. While we
applaud the Task Force for the “B” grade recommendation for HCV testing
of persons who inject drugs (PWID) and other persons with identified
risks for infection as a step forward, we fear that a “C” grade
recommendation for baby boomers will fail to identify a large portion of
HCV-infected individuals.

We appreciate the work that
the United States Preventative Services Task Force (USPSTF) does and
understand the systematic review of many comprehensive bodies of
evidence; however, it is critical that we prioritize the identification
of HCV-infected baby boomers in order to meet the goals of the
Department of Health and Human Services’ Viral Hepatitis Action Plan.
Of the estimated 3.2 million persons living with HCV, 45 to 85 percent
remain unaware of their infection and are not linked to the life-saving
care and treatment that are needed to avoid progression to liver
disease, cirrhosis or liver cancer. Persons born between 1945 and1965
have the greatest risk for HCV related morbidity and mortality, and
therefore, would see the greatest benefit from HCV screening.

As
you know, earlier this year, the Centers for Disease Control and
Prevention (CDC) released new HCV screening guidelines recommending that
providers offer the screening to anyone born in this birth cohort. The
recommended grade of a “C” falls disconcertingly short of meaningfully
implementing the CDC’s recommendation. The USPSTF states that there is
only a “small benefit” for testing those who do not have symptoms,
despite the fact that HCV can remain asymptomatic for years.

Of
additional concern is the fact that the USPSTF does not have a
consistent public definition for the “C” grade. While a “C”
recommendation appears to put the decision to screen in the hands of the
individual physician, the USPSTF notes that the “C” statement is
“undergoing revision.” This could create a significant level of
confusion as physicians determine how to incorporate the recommendation
into practice.
CDC took an important first step in
changing the testing paradigm around HCV for the better and improving
health outcomes for millions of Americans. CDC’s guidelines are based on
a systematic review of a comprehensive body of evidence, evidence that
we encourage the USPSTF to use to align itself more closely with the
CDC’s recommendations. Make no mistake, failure to change this
recommended grade will affect millions of Americans who will not be
screened by their providers because there is no reimbursement mechanism
for C grade recommendations.

The USPSTF took a major
step forward by endorsing risk-based screening for people with histories
of injection drug use, the leading cause of new infections today.
However, history shows that risk-based screening recommendations, while
perhaps theoretically most cost effective, are not most effective in
practice. For example, the early recommendations for hepatitis B viral
(HBV) immunization for neonates were originally risk-based for infants
born to known HBV carriers, offspring of Asian and Pacific Islanders, or
of mothers with known risk factors. This recommendation was so poorly
followed that it was changed to universal neonatal immunization. After
this is when HBV prevalence began to fall.

Another
reason to support an age-based cohort recommendation, as opposed to a
risk-based recommendation, is that a significant percent of hepatitis C
infected patients do not know or else deny risk factors for hepatitis
C. Yet another reason is that primary care physicians do not routinely
inquire as to if a patient has a history of intravenous drug use. In
any of these cases, the decision to test is not triggered. An age-based
cohort recommendation addresses these issues. We are aware that USPTF
uses literature based review in their assigning of a grade. We ask that
the literature related to the greater effectiveness of age-based methods
be utilized as well. Although a risk based recommendation is clearly
the more intellectually elegant and theoretically cost effective, the
reality is that it is only effective for those in whom risk is
adequately ascertained, resulting in an extremely narrow impact.

An
A or B grade recommendation can have a substantial impact on expanding
screening access to millions of people living with HCV who do not know
their status, bringing more people into care and treatment and
decreasing new HCV infections. It will also have implications for
insurance coverage of HCV testing, as USPSTF grades guide reimbursement
requirements for private insurers, Medicare, and Medicaid. This is
especially important given that development of new therapies for HCV is
advancing rapidly. Data recently presented at the annual American
Association for the Study of Liver Diseases meeting suggests that highly
effective, safe, short acting and all-oral treatment regimens can be
expected within the next 12 to 18 months. These advances will reduce
the harms of HCV, while increasing the benefits of testing, care, and
treatment.

With the HCV treatment
pipeline changing, new therapies achieving successful results, revised
and expanded CDC guidelines, and the HHS Viral Hepatitis Action Plan
that focuses on identification of people living with viral hepatitis,
it is imperative that USPSTF recommendations are congruent with federal
priorities and current medical knowledge. We thank you for your time and
look forward to working with you in the future. If you have any
questions, please contact A.J. Bhadelia with Rep. Mike Honda’s office (aj@mail.house.gov), Scott Goldstein with Rep. Johnson’s office (scott.goldstein@mail.house.gov) or Robb Walton with Rep. Cassidy’s office (robb.walton@mail.house.gov).

Jamie Barnard may feel like a lab rat for the
next six months as she gives herself weekly interferon injections that
she hopes will keep her hepatitis C virus in check for the rest of her
life.

Earlier this month, specialists hovered over
Barnard as she pulled the trigger on the first injection pen in a
conference room at Salt Lake City’s Fourth Street Clinic, a health care
center that caters to the homeless population and people who have
recently transitioned into housing.

The hepatitis C treatment can be costly. The
clinic’s patient assistance coordinator, Verthanial Benally, has worked
to get a wide array of prescription medications at free or reduced
costs for the clinic’s steady stream of clients. Drugs are also donated,
said Cole, enabling the clinic to provide hepatitis C shots to patients
at no cost. Without the donations, one shot alone can cost $500.

The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA treated patients. To read the entire study, click here Share This PageFollow Us … Continue reading → The post The study is aimed at assessing the safety and immunogenicity of HCV […]

The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. Hypothesis: The efficacy and tolerability of all DAA-based regimens in the clinical practice is different to what is … Continue reading → The post Real-life Security and Efficacy of DAA-based Therapy in 1,000 […]